Factors Associated With Health-related Quality of Life and Social Participation of Patients With Multiple Myeloma and Their Caregivers: a Mixed Methods Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Health related quality of life (HRQoL)
研究概览
简要总结
Individuals with multiple myeloma (MM) are vulnerable because of the effects of systemic organ damage and the side effects of treatment. A decline in patients' health-related quality of life (HRQoL) and a compromised participation in everyday life was reported. The diagnosis of MM negatively affects the principal informal caregiver. This is a concurrent exploratory mixed methods study that involves the use of a quantitative and a qualitative approach. For the quantitative study, aims are to describe any possible relation between the identified factors with HRQoL and participation in individuals with MM and with reactions to caring and self-efficacy of caregivers. For the qualitative study, aims are to investigate "how" and "why" the disease impacts the daily life of individuals with MM and their caregivers. The final analyses will be based on the comparison of the results of the quantitative phase and the results of the qualitative phase.
详细描述
MM is a hematological disease caused by an uncontrolled proliferation of plasma cells. Individuals with MM are vulnerable because of the effects of systemic organ damage and the side effects of treatment. A decline in patients' functional status, the deterioration of health-related quality of life (HRQoL) and a compromised participation in everyday life was reported. Moreover, the diagnosis of MM occurs within the context of a family and it negatively affects the principal informal caregiver.
According to the International Classification of Functioning, Disability and Health, participation in daily life plays a key role in rehabilitation as it confers a sense of normalcy to life. Comprehensive rehabilitation intervention aiming at improving HRQoL and facilitating participation has never been implemented with this aim.
From previous systematic reviews, it emerges that patient reported outcomes (PRO) of individuals with MM have been studied mainly in randomized clinical trials, but also few observational studies have been published, conducting also in Italy. In the province of Reggio Emilia, population-based data concerning the HRQoL of individuals with MM have never been collected, as well as for their caregivers. Needs related to participation in everyday life of individuals with MM and their caregivers were mainly studied through qualitative approach.
Although qualitative data are essential in describing a phenomenon, it is currently not possible to quantify the degree of loss of participation in everyday life or to identify patients most at risk of social isolation. As a counterpart, qualitative approach may explain those situations that quantitative approach cannot verify (e.g., reasons behind conditions of social vulnerability). For these reasons, it seems appropriate to explore the patients' perceived HRQoL and participation from both quantitative and qualitative perspectives, as well as the caregivers' burden, by integrating these data. In this study, needs and difficulties in accomplishing the relevant activities and roles as well as the description of factors that act as facilitators or barriers to HRQoL and participation will be identified to screen patients that might benefit most from rehabilitation. Based on these data, comprehensive and tailored rehabilitation may be planned in future studies and tested for its impact on HRQoL and participation.
This is a concurrent exploratory mixed methods study that involves the use of a quantitative and a qualitative approach. The quantitative is the main study, while the qualitative is the sub-study. Participants of the qualitative study will be a sub-group of those recruited in the quantitative study. In this mixed methods study, we will recruit individuals with MM and caregivers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Comorbidities that limit collaboration (e.g., dementia, severe psychiatric disorders).
- •_________________________________________________________________
- •Inclusion criteria for caregiver will be:
- •having a loved one (individual with MM) who have participated in the quantitative phase
- •being the primary informal caregiver
- •adulthood (≥ 18 years)
- •speak Italian fluently
结局指标
主要结局
Health related quality of life (HRQoL)
时间窗: 24 months
HRQoL in individuals with MM measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Multiple Myeloma Module (EORTC) QLQ-MY20. The QLQ-MY20 consists of two subscales on disease symptoms (6 items) and side-effect of treatment (10 items), one functional scale on future perspective (3 items), and one single item on body image. All the subscales and single-item measures of the QLQ-MY20 range in score from 0 to 100. A higher score for disease symptoms and side-effects of treatment indicated worse outcomes, while a higher score in the body image and future perspective indicated better outcomes.
Open-ended questions of a semi-structured interview that was written by researchers and clinicians and with the support of expert individuals with MM and their caregivers to collect the disease-related experiences and its consequences on daily life
时间窗: 24 months
Themes describing the disease-related experiences and its consequences on daily life of individuals with MM and their caregivers generated through the listening of their narratives
Participation
时间窗: 24 months
Participation in individuals with MM measured by the World Health Organization Disability Assessment Schedule (WHODAS 2.0). WHODAS 2.0 captures the level of functioning in six domains of life: cognition (6 items), mobility (5 items), self-care (4 items), getting along (5 items), life activities (8 items), participation (8 items). Each item of the WHODAS 2.0 is assigned a score between 1 and 5 (5-point Likert scale). The higher the score, the higher the level of disability.
Reactions to caring
时间窗: 24 months
Reactions to caring in caregivers of individuals with MM measured by the Caregiver Reaction Assessment scale (CRA). The CRA is composed of 24 items categorized in 5 subscales: impact on schedule (5 items), impact on finances (3 items), lack of family support (5 items), impact on health (4 items) and caregiver esteem (7 items). Each item is assigned a score between 1 and 5 (5-point Likert scale). The higher the score for the impact on schedule, impact on finances, lack of family support, and impact on health domains, the more the negative impact of caregiving activity, while a higher score in the caregiver esteem domain indicated more positive impact of caregiving activity.
5. Self-efficacy
时间窗: 24 months
Self-efficacy in caregivers of individuals with MM measured by the Caregiver Inventory (CGI-I). It is composed of 21 items categorized in four subscales: managing medical information (3 items), caring for the care recipient (7 items), caring for oneself (5 items), managing difficult interactions/emotions (6 items). Each item is assigned a score between 1 and 9 (9-point Likert scale). Higher scores indicate greater self-efficacy for caregiving.
次要结局
未报告次要终点